Coherus BioSciences, Inc. (CHRS) announced positive developments in its first quarter 2024 earnings call, highlighting significant revenue growth driven by recent US FDA approvals and market launches of LOQTORZ and the UDENYCA on-body injector.
The company is actively pursuing strategies to strengthen its balance sheet, reduce debt, and enhance shareholder value through product development and strategic partnerships. Coherus BioSciences is optimistic about continued revenue growth and market share expansion for its products, despite not providing specific guidance for 2024.
Key Takeaways
- Coherus BioSciences received two US FDA approvals in Q4 2023 for LOQTORZI in nasopharyngeal carcinoma and the UDENYCA on-body injector.
- The company has seen revenue growth following the successful market launch of both products.
- Focus on balance sheet improvement through divestitures and non-dilutive financing.
- R&D pipeline showing promise with positive data at medical conferences.
- LOQTORZI now covered by payers for over 85% of medical benefit lives.
- UDENYCA's on-body injector driving revenue growth and market share.
- Immuno-oncology portfolio expansion through internal development and external partnerships.
Company Outlook
- Coherus BioSciences aims for peak market share and penetration for LOQTORZI within three years.
- UDENYCA is expected to be a primary growth driver in 2024, with clinics showing a preference for all three of its presentations.
- The company remains confident in its ongoing revenue growth and progress with key products.
Bearish Highlights
- No specific financial guidance for 2024 was provided.
- The company acknowledges the uncertainty in growth trajectory due to the early stages of product launches.
Bullish Highlights
- Market share for pegfilgrastim grew from 10% to 25% quarter-over-quarter.
- LOQTORZI is expected to capture a significant portion of the market across various settings.
- Payer coverage for the company's products has doubled this year, supporting market share growth.
Misses
- There were no specific misses discussed in the earnings call summary provided.
Q&A Highlights
- The on-body product is expected to be a significant growth driver for UDENYCA in 2024, tapping into new market segments.
- The company is working towards reaching cash flow positivity by 2024, buoyed by increased payer coverage and market share growth.
- The year 2024 is considered to be predictable in terms of revenue growth, although the exact trajectory remains uncertain.
Coherus BioSciences, Inc. has demonstrated a strong start to 2024, with its strategic initiatives and product launches beginning to bear fruit. The company's focus on strengthening its financial position and expanding its product offerings sets a positive tone for its future prospects. As Coherus BioSciences continues to execute its plans, investors and market watchers alike will be keen to follow its journey towards achieving its growth targets and enhancing value for its shareholders.
InvestingPro Insights
Coherus BioSciences, Inc. (CHRS) has made impressive strides in revenue growth, as evidenced by the substantial 64.63% increase in revenue over the last twelve months as of Q1 2024. This is further bolstered by an even more remarkable quarterly revenue growth of 137.58% in Q1 2024. These figures underscore the company's successful market launches and FDA approvals, which have been pivotal in driving sales.
InvestingPro Tips suggest that while the company is quickly burning through cash and analysts do not expect it to be profitable this year, Coherus BioSciences has managed to maintain a solid liquidity position. Its liquid assets surpass short-term obligations, providing some financial cushion. Moreover, a large price uptick of 33.33% over the last six months indicates growing investor confidence in the company's market performance and future prospects.
Despite these positive trends, it's important to note that Coherus BioSciences does not pay a dividend to shareholders, which may influence investment decisions for those seeking income-generating stocks. Also, the company's P/E ratio stands at -3.67, reflecting its current lack of profitability over the last twelve months.
For those interested in a deeper analysis, there are additional InvestingPro Tips available on the company's performance and outlook. To explore these insights and to make more informed investment decisions, consider using the promo code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
Full transcript - Charming BioSciences Inc (CHRS) Q1 2024:
Operator: Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to Coherus BioSciences, Inc. First Quarter 2024 Earnings Conference Call. All lines have been placed on mute to prevent any backward notes. After the speaker's remarks, there will be a question-and-answer session. [Operator Instructions] I would now like to turn the conference over to Jamie Taylor, Head of Investor Relations. Please go ahead.
Jamie Taylor: Thank you, operator. Good afternoon, and welcome to Coherus BioSciences first quarter 2024 earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus; Bryan McMichael, our Interim Chief Financial Officer; Paul Reider, our Chief Commercial Officer; Rosh Dias, Chief Medical Officer; and Theresa LaVallee, our Chief Development Officer. Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherus’ current expectations about future events. These statements include, but are not limited to, the following: Our ability to advance our pipeline, projections of future growth, revenue, expenses, headcount, and debt levels. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements. These statements are not guarantees to future performance and are subject to substantial risks and uncertainties, including risks and uncertainties inherent in the clinical drug development process that are discussed in our press release that we issued today, as well as the documents that we file with the SEC. Forward-looking statements provided on the call today are made as of this date and we undertake no duty to update or revise any forward-looking statement. And now, I'll turn the call over to Denny.
Denny Lanfear: Thank you, Jamie. Good afternoon, everyone, and thank you for joining us on our call today. As we open the call, let me emphasize two things: First, the strength of our first quarter results; and secondly, the strategic initiatives, we are successfully executing to position our company for long-term success. As you are aware, in the fourth quarter of 2023, we received two US FDA approvals for products vital for our commercial portfolio. First, LOQTORZ for nasopharyngeal carcinoma, a rare and devastating cancer, for which is the only FDA-approved therapies. And the UDENYCA on-body injector an innovative drug delivery mechanism with novel features that opens up large portions of the pegfilgrastin market that we previously could not access. In the last three months, we launched both products, leveraging synergies derived from our company's focus on oncology. Our Chief Commercial Officer, Paul Reider, will describe these launches in more detail in just a moment and share with you the enthusiasm with which both products have been received in the market and revenue growth each has experienced this quarter. Recently launched innovative products are fully aligned to our company's mission for extending the survival of cancer patients. On the development side, in just a moment, Dr. Theresa LaVallee and Dr. Rosh Dias, will describe how our R&D pipeline is advancing to plan, with impressive data consistently presented at major medical conferences and more to come. Across every team dimension, the company is executing well and to plan. Regarding strategic initiatives, we are focused on exercising our strategic optionality to strengthen the company's balance sheet and enhance long-term value for our shareholders consistent with our mission. This is particularly relevant to the commitment we have demonstrated, strengthening Coherus' capital structure, where strong progress has been made. I'll highlight just two of the recent steps and developments. Early in the first quarter, we announced the divestiture of CIMERLI a non-core, non-oncology asset for $170 million upfront cash payment, plus an additional $17.8 million in cash for inventory. This divestiture has allowed us to pay down a large portion of our $250 million term loan debt, while reducing interest costs, reducing headcount and overhead costs and significantly improving our gross margins. Today, we announced a new non-dilutive debt and royalty financing, which fully repays the remaining $75 million, which was otherwise due in October of 2025. With this transaction completed, we have now reduced our structured term loan debt by 85% over the recent three-month period, while the remaining $37.5 million and moving the due date out five years to 2029 with no springing maturity. Timeline for debt maturity under this agreement extends beyond that, the development horizon of our products. And with that, let me turn the call over to Paul Reeder. Paul?
Paul Reider: Thank you, Denny, and good afternoon, everyone. With the ophthalmology divestiture, we are now an oncology-centered commercial organization which supports our overarching business objectives. The ongoing oncology launches like, LOQTORZI, UDENYCA ONBODY, UDENYCA autoinjector, enable singular focus on driving top line revenue. We are executing to plan. And we're pleased with our progress. Regarding the quarter's performance, total net product revenue was $76.7 million, a 137% increase over Q1 2023. For our core oncology brands, Q1 UDENYCA net revenue was $42.7 million, an 18% increase quarter-over-quarter and a 63% increase over Q1 2023. LOQTORZI net revenue was $2 million in the quarter, still early in launch and in line with our expectations and with new patient accrual momentum building. Now for our non-core products, Q1 net revenue for YUSIMRY was $3.9 million, 77% growth quarter-over-quarter. And finally, CIMERLI, given the deal closed on March 1st, net revenue for the quarter was $28.2 million and only reflects sales for January and February. I'll now speak in more detail about our core oncology assets, starting with LOQTORZI. The commercial launch of LOQTORZI now establishes Coherus in the immuno-oncology therapeutic area, serves as the foundation upon which we will commercialize our exciting pipeline of I/O products. LOQTORZI has a broad label and is approved in combination with system for first-line treatment of adults with Metastatic or with Recurrent Locally Advanced NPC and as a single-agent, adults with Recurrent unresectable or metastatic NPC with disease progression on or after a Platinum‐Containing Chemotherapy. Today, the standard of care is chemotherapy. So our ambition is to establish LOQTORZI plus chemo as the new standard of care and offer MPC patients that hope for greater survival based on the final overall survival results from the JUPITER-02 trial in which LOQTORZI plus chemo resulted in a 37% reduction in the risk of death versus chemotherapy alone. Educating MPC treating oncologists on these clinical data remain a top priority, and it's being amplified by the advocacy of the nation's leading MPC opinion leaders who have affirmed the strength of the LOQTORZI clinical data and its position as the new standard of care. Since launch we've achieved a series of milestones necessary to enable broad prescribing over the course of 2024 and beyond. I'll highlight four examples. First, LOQTORZI was included in NCCN, ASCO and Clinpath guidelines. In NCCN LOQTORZI is the only PD-1 with Category 1 designation for first-line use and the only preferred regimen in second line plus. Second, payer coverage has been confirmed now on greater than 85% of medical benefit lives and health plans, including Medicare fee for service, CareAdvantage and national and regional commercial plans. Third, among the top academic research hospitals, LOQTORZI was added to the formulary on 55% of the 33 NCCN institutions with the remaining institutional reviews scheduled, formulary position is highly expected to be achieved with all NCCN institutions by the end Q2 2024. Finally, product-specific permanent J-Code has been granted by CMS will take effect July 1, 2024. This will enable more efficient billing processes and speed the time to reimbursement for providers. Based on LOQTORZI these labeled indication, We estimate approximately 2,000 patients will fall within the addressable market opportunity for LOQTORZI with a hospital formulary conversion process underway, the enthusiasm, with which the community is embracing the product, we're building momentum as the launch continues. In Q1, approximately 80 patients received LOQTORZI treatment across all lines of therapy. Combination with chemo or as monotherapy, which was in line with our expectations, we are pleased that the launch is progressing to plan. Now turning to UDENYCA, UDENYCA delivered another quarter of revenue growth driven by continued strong execution. The strength of our execution is fueled by three drivers. First, the commercial launch of UDENYCA on body, a novel proprietary state-of-the-art delivery system for pegfilgrast enabling UDENYCA to now compete across the entire pegfilgrastim market. Second, UDENYCA is the only pegfilgrastim brand with three device options to meet the unique needs of providers and patients. The strength is our competitive position it allows us to compete on factors other than price. Third, we come into 2024 with payer coverage, nearly two times that of 2023 and opening up access to significantly more patient lives. As for key performance indicators for the quarter, UDENYCA franchise demand grew 36% quarter-over-quarter, driven primarily by the pre-filled syringe and auto-injector presentations. In addition, franchise market share was 25%, an increase of 10 market share points quarter-over-quarter. Regarding the launch of UDENYCA on-body customer receptivity has been very positive. Specifically, providers are pointing to UDENYCA Onbody five-minute injection time, which is approximately 90% faster medication delivery in Neulasta Onpro. This is noted as a key differentiator, and this differentiation is translating into strong customer adoption. Summary, UDENYCA franchise now offers providers and patients to total solution, and we expect continued unit and revenue growth with a focus on improving margins over the course of 2024. I'll now turn the call to Dr. Rosh Dias, our Chief Medical Officer. Rosh?
Rosh Dias: Thanks very much, Paul, and good afternoon, everyone. LOQTORZI toripalimab with a profound survival advantage demonstrated in nasopharyngeal carcinoma, together with additional positive efficacy data sets published across a variety of tumor types continues to form the foundational element of our immuno oncology portfolio. As an IO company with an approved and highly efficacious PD-1, that affords us the opportunity to prosecute three distinct strategies for further development from the wider variety of tumor types. Firstly, combinations with our own internal pipeline, which consists of 3 competitively well-positioned assets, highly focused development plans, all of which are progressing according to plan, casdozokitug our IL-27 targeted antibody, CHS-114, our CCR8 targeting antibody and our anti ILT4. Secondly, development opportunities where toripalimab is studied in combination with novel compounds with INOVIO term registration opportunities fully funded by partner companies in Phase 3 registration enabling studies, such as the INOVIO vaccine combination study in head and neck squamous cell carcinoma sponsored by INOVIO where we're providing toripalimab supply and the ongoing Junshi BTLA-torepalumab combination study in limited stage small cell lung cancer. And thirdly, development opportunities for toripalimab with partner companies that have earlier phase novel compounds for which they are looking for a PD-1 partner. Respect to our internal pipeline, let me first start with Casdozo. We remain excited about the potential of Casdozo in both non-small cell lung cancer, where we have demonstrated monotherapy activity in PD-L1 refractory subjects in the advanced setting and also in hepatocellular carcinoma, where we have demonstrated encouraging overall response rate in the first-line advanced setting. We're taking forward the non-small cell lung cancer data with our Phase 2 study that is currently ongoing and is active in the US and where we remain on track to report out data towards the end of this year or early next year. Our second development program in casdozokitug in advanced HCC also remains on track to start in the second half of this year, building upon the promising data presented earlier this year at ASCO GI. Turning to CHS-114, our CCR8 afucosylated antibody, we've continued to make good progress through dose escalation and are now moving on to the next stage of the study with expansion into head and neck squamous cell carcinoma where the disease leakage is particularly strong. We're excited that abstracts has been accepted for presentation at ASCO in a few weeks time for further detail based the dose escalation portion of the trial. Theresa will speak more about the status of our IoT4 program and we'll highlight data presented at the recent AACR meeting. Next, with respect to our pivotal partnered programs with near-term registration opportunities. Our partnership with Innovia continues with the Phase 3 registration-enabling study in HPV-positive locally advanced head and neck squamous cell carcinoma currently actively in development. In addition, the toripalimab BTLA Phase 3 combination study in limited stage to more cell lung cancer-led by our partner, Junshi, continues to progress in the U.S. and also other multiregional sites. And this serves as a further example of the potential of toripalimab to act as a foundational element for novel combinations. Finally, with respect to earlier stage novel combinations, we were delighted to announce yesterday that toripalimab was selected by Cancer Research Institute as the PD-1 backbone for exploration with EMV therapeutics endothelin B inhibitor within a platform ovarian cancer study exploring novel combinations in this patient population that historically has been underserved by immunotherapy. Selection of toripalimab by CRI provides further validation of our strategic trial approach of utilizing toripalimab as an investigational PD-1 backbone in the areas outside NTT. I'll now turn the call over to Dr. LaVallee, our Chief Development Officer, Theresa?
Theresa LaVallee: Thank you, Rosh, and good afternoon, everyone. I'm pleased to update you on additional progress and our efforts to pursue development of our tumor microenvironment, or TME, focused pipeline. We have two approaches; combinations broadly with immune activators with partners, and the internal development plans focused on combination with LOQTORZI. The casdozokitug clinical data in non-small cell lung cancer in HCC that were presented in December 2023 and January 2024 have demonstrated clinical efficacy in early clinical studies. Importantly, the study show a favorable safety profile, lending casdozo combination treatments and equal importance, immune activation in cancer patients. In the casdozo Phase 1 study, the biomarker data show an casdozo doses of 10 mg per kg or higher but not at 3 mg per kg or lower that IL-27 signaling is inhibitedaAnd further, NK and T cells are activated. While rebalancing the immune system with anti-cytokine antibodies is well established in inflammatory diseases, such as rheumatoid arthritis, inflammatory to disease, and psoriasis, this approach has not yet been successfully demonstrated for the treatment of cancer. Casdozokitug is an antagonist and first-in-class. It blocks IL-27, which is in the IL-23, IL-12 IL-6 family of cytokines, a family that has multiple approved antibody drugs in inflammatory diseases. Our scientific adviser, Dr. Christopher Hunter from University of Pennsylvania was honored for his research on IL-27 with the distinguished lecture at the American Association of Immunologists Congress in Chicago on May 4th. In Dr. Hunter's lecture, he described the basic research of mouse models to understand the immune regulatory role of IL-27 and how the absence of IL-27 results in immune pathology due to an overactive immune system. Specifically, this regulated and activated T cells and NK cells. Interestingly, these effects are most notable liver, bone, and brain tissue. In translation of this work to cancer and treatment of patients with casdozokitug showing antitumor activity in lung and liver cancer is very exciting. This strong line of sight for tumor indications where IL-27 biology is critical for regulating immune response allows Coherus to have a focused development plan. I'm also proud to say that at the recent AACR meeting, our team presented IND-enabling studies for ILT4 antibody CHS-1000. CHS 1000 is our first internally discovered and developed IO drug candidate. We remain on track for FDA feedback on the IND in second quarter 2024. I'll now turn the call to Brian McMichael.
Bryan McMichael: Thank you, Theresa, and good afternoon, everyone. Since Denny covered the updates to our capital structure and Paul covered revenues, I will focus on the rest of the P&L and cash. Cost of goods sold during Q1 2024 was $34.6 million. Excluding the impact of the inventory write-down in Q4, COGS would have decreased $3 million or 8% from Q4 2023. R&D decreased $5.7 million and 17% from Q1 a year ago, primarily reflecting savings from reduced headcount and reduced the development costs on biosimilars partially offset by investments in our IO pipeline. SG&A increased to $7.4 million and 15%, driven by a net $6.8 million charge in Q1 2024 associated with the noncash write-off of NZV930, which is now licensed obtained in the Surface Oncology (NASDAQ:SURF) acquisition that was terminated by Novartis (SIX:NOVN). The first quarter of 2024, we reported net income of $102.9 million or $0.83 per diluted share compared to a net loss of $75.7 million or $0.96 per share diluted share for the same period in 2023. Non-GAAP net loss per share, which excludes the gain on divestiture and the net charge associated with the termination from Novartis mentioned earlier, was $35.8 million or $0.32 per diluted share in Q1 2024 compared to $59.5 million or $0.75 per diluted share for the same period in 2023. Cash and cash equivalents and investments in marketable securities were $259.8 million as of March 31, 2023 compared to $117.7 million at year-end. As noted earlier, we used the cash on hand to pay $175 million in principles after the quarter ended Today we are reiterating our expected range combined 2024 R&D and SG&A expenses of $250 million to $265 million. This guidance includes approximately $40 million of stock-based compensation and excludes business development activities and other unforeseen activities. With that, I will turn the call back over to Denny for closing remarks.
Denny Lanfear: Thank you, Bryan. As we have emphasized throughout our remarks today, we are executing well on our four-part plan to deliver shareholder value. First, driving the top line of our revenues and secondarily, controlling our operating expenses. We are making great progress advancing our pipeline of tumor microenvironment focused assets. And lastly, as I disclosed, improving our capital structure. I'm fully confident in both the progress we are making and, of course, we have charged as an oncology company. Operator, we're now happy to open the line for questions.
Operator: The floor is now open for questions. [Operator Instructions] Your first question comes from the line of Yigal Nochomovitz with Citi.
Unidentified Analyst: Hi, guys. This is Ashwin coming on for Yigal. Thanks for taking my questions. And congrats on the quarter I joined a little bit late, so I apologize if I missed this, but how are you thinking about the contribution each presentation of UDENYCA to the revenue mix for the quarter? And more importantly, how is that going to look like moving forward? I kind of assume that weighting will increase towards the new presentations, but I'm wondering how you're thinking about it.
Jonathan Neman: Hi. Thank you very much for your question. Paul Reider will be happy to further describe the contribution revenues for the three presentations that we now have on the market. Paul?
Paul Reider: Yes. So the -- in the first quarter, the prefilled syringe still represented the largest share of our of our SKU mix. It was around 90%. The auto-injector is around 8%, and the odd bodies came in around 2%. And recalling that we launched mid-quarter. So nearly at about half of the quarter to be on body. So that's the breakdown of the SKU mix. It varies a little bit by segment. So clinics and hospitals tend to customize the SKU that works best for them, which is exactly how we are now competitively positioning the franchise, and we're the only franchise that could offer providers and patients three different options to meet the unique needs of each individual patient or how they deliver pegfilgrastim. So you could see how that differentiation has translated into market share growth, 10% points quarter-over-quarter to 25%. And so we're going to continue to drive that differentiation as the remainder of the year unfolds.
Jonathan Neman: Paul, how do we see the market share of each of the presentations evolving through the rest of the year? Do you have any line of sight on that?
Paul Reider: Yes. I think it's still early in the on-body launch. So we are gaining feedback from customers as where it's fitting in. I can tell you right now that it's moving primarily in the clinic segment and also different segments of the hospitals. But I think we're still going to see throughout this year, at least the prefilled syringe still holding a good percentage of the SKU mix with the remainder being auto injector and the on-body. But the odd body growth has largely been in the clinic segment. We would expect that to continue throughout the year.
Jonathan Neman: Thank you for your question.
Unidentified Analyst: Got it, that's super helpful.
Operator: Next question comes from the line of [indiscernible]. Your line is open.
Unidentified Analyst: Hey guys, thank you so much for taking my question. For Unlock Tour Z, you mentioned that the launch is going well. Can you maybe provide some color on whether the drop has been used more in front line or second line setting? And also, I think it's a new launch and it's relatively rare to see, so you mentioned it can take time to get on the formularies. You talked about 55% being on 55% of the 33 NCCN hospitals. Is this in line with your expectations? Thank you.
Dennis Lanfear: Thank you for your question. Paul, I'd be happy to comment a little bit about front line versus second line utilization and the 55% NCCN conversion. Paul?
Paul Reider: Yeah. Thanks for your question. So, going back to the labeled indication for Lock Tour Z, it's indicated in the earlier stage of the recurrent locally advanced patients and that we are seeing Lock Tour Z use in those patients. It's typically, in that case, combined with chemotherapy. What we also saw, as expected, was contribution of Lock Tour Z in both the metastatic setting in both the front line and the second line plus. And in those cases, if it's front line, it was being combined with chemotherapy consistent with the Jupiter 2 trial and our labeled indication and more as monotherapy when it's second line plus. So, as expected, it's being positioned all throughout the indicated uses. The only thing, and I think you mentioned this, was like when in the second line and the later lines of therapy, these patients' duration is likely going to be less. And if when we have eligible patients, though, that are already on an off-label PD-1, those will be difficult for, Lock Tour Z to capture. So, the value of the franchise will occur over the next three years as we, build up the large majority of the new standard of care in the front line setting. As for the formularies, yeah, that's very much in line with our expectations. Academic medical centers have processes, it takes time to go through those formularies. And as I mentioned, we would expect all the remaining NCCN institutions, to be completed by the end of the year.
Unidentified Analyst: Great. Thank you. Thank you, Kripa.
Operator: Next question comes from the line of Michael Nedelcovych with TD Cowen. Your line is open.
Michael Nedelcovych: Thank you for the questions. I have two. The first is also on Lock Tour Z. Your progress in getting formulary access is impressive. Is that basically the lever that's needed to be pulled in order to displace any residual off-label prescription of other checkpoint inhibitors? Or is there additional work that needs to be done from a marketing or physician education perspective? So, that's one question. And then my second question is on UCINRE. I think in the past you've suggested that 2025 could be an inflection year for a biosimilar like UCINRE based on some of the IRA provisions. Are you still thinking about it that way? Does UCINRE have a bright future ahead? Or what is your latest thinking on UCINRE's outlook? Thanks.
Dennis Lanfear: Great. Thank you for the question. I'll let Dr. Raj Diaz firstly address the issue of the therapy selection decision that physicians now have with the launch of LOQTORZI, and then Paul can secondarily talk about CIMERLI, Rosh?
Rosh Dias: Yeah. Thanks very much for the question. I would say doctors tend to be pretty evidence-driven. And we have three things that no other PD-1 has. First of all, we have an indication. Secondly, we have a profound survival advantage in the first-line setting, 37% risk reduction of death, and again, that's in the context of negative trials with other PD-1s in nasopharyngeal carcinoma. And then the third thing we have is also a preeminent positioning on the NCCN. So first line, we are the only category one designated IO therapy and in second line and beyond, we are the only preferred regimen actually. But I think as we start seeing patients, I think these three things are key and both team is continuing to message on those three things.
Denny Lanfear: Thank you. Paul, do you want to comment a little bit about our expectations for CIMERLI going to 2025 with IRA?
Paul Reider: Sure, Denny. Thanks for your question, Mike. For 2025, formulary negotiations are ongoing. And CIMERLI and Coherus are actively engaged in that process. So we continue to believe that I think the point where we see even greater inflection of biosimilars coming out of adalimumab space. So I think we're well-positioned there based on our price point and the value that this product brings to the healthcare systems and patients.
Michael Nedelcovych: Thank you.
Denny Lanfear: Thank you for your question.
Operator: [Operator Instructions] Your last question comes from the line of Balaji Prasad with Barclays. Your line is open.
Unidentified Analyst: Good afternoon. It’s Shaun [ph] on for Balaji. Thanks for taking our question. Just a quick follow-on question on the UDENYCA franchise, and you recently announced that the license in packages on boarding injector and pre-filled auto-injector, and they expect to submit the BLA [ph] in the first quarter of 2025. And there are a few other players that are trying to get into this landscape. So what is your expectation for the request from on-body injector landscape and the entire market for the next two to three years? And do you have any plans or mechanism to build and defend your market shares against those potential new entrants? Thank you.
Denny Lanfear: I'm sorry, I don’t understand, we're having a difficult time hearing you. Want to understand your question. Is your question with respect to future entrants, in the on-body space with the like progesterone market or with auto-injectors?
Unidentified Analyst: Progesterone market, especially the on-body injector and the auto field – pre-filled auto injector as Amneal recently announced that they have something in plan and they plan to sell BLA in first quarter of 2025?
Denny Lanfear: Paul, would you like to address how we view the competition in regress to market for future auto injectors?
Paul Reider: Yeah. Well, first of all, we've been operating in this pegfilgrastim market now. We're in our sixth year and maintain one of the leadership positions here. So what we're going to continue to do is focus on our business and the positioning of UDENYCA, which is to be the total solution for providers and patients. And we're doing this, as I mentioned, because today, we've got all three presentations. It's tried and true and well established in the market. Secondly, we've got strong payer coverage. And so that's being recognized by payers. UDENYCA brand is a go-to brand because of all of these benefits that we bring to not only the consistency in the marketplace to predictability but also the high quality and reliability of this brand. So we'll be prepared for any competition if anybody else comes, but we believe we'll continue to be well-positioned to compete and win whenever that landscape unfolds.
Denny Lanfear: Thank you, Paul. The other point that I would make is consistent with Paul's remarks, our on-body injector represents an innovative de novo highly sophisticated device with a 5-minute injection time. and the enthusiasm with which it has been received by the market, the physicians and the patients is due to that. We believe there are significant technical hurdles to such an approach and we investigated a number of approaches before settling on this one. So we think this is very important. We think we got it right. But lastly, as Paul said, we are first competitors in the pegfilgrastim market and our track record over the last six years demonstrates that. We are the only team with all three presentations, each filling of particular need in the market. So I believe that we're very confident in our ability to compete and remain successful and grow share in this market.
Unidentified Analyst: Thank you.
Operator: Another question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open.
Douglas Tsao: Good afternoon and thanks for taking my question and congrats on the progress. Obviously, there are a number of sort of dates that you need to clear in terms of the ramp-up for LOQTORZI in particular, getting onto formulary. How quickly do you think you can get through those and sort of have access at sort of the most of the majority of the market? And what other steps do you think we might need to -- you might need to clear before we really start to see an acceleration in the revenue trajectory?
Denny Lanfear: Thanks for your question, Doug. Paul, would you like to comment a little bit on the gating of the adoption of LOQTORZI and how we do that?
Paul Reider: Yes. Thanks for your question, Doug. Yes. So obviously, the payer coverage was -- is the first one, and that's well established. And I don't really foresee any further hurdles on the payer side. The second gate is now that we've got the NCCN guidelines, what we have to ensure now is in each of the accounts that the guidelines that are translated into the order sets so again this enables the doctor at the time of prescribing -- when they click through the order set that -- LOQTORZI chemo combination is there, that's ongoing, but that will typically settle in here over this next quarter. Then, Doug, I really think the next gate is just sort of washing out all of the current patients that are on current off-label PD-1s and establishing the new patients with LOQTORZI as the new start and getting anybody that on chemo today or not on a PD-1 treated with LOQTORZI. And that's just going to take a continued effort in terms of promotion, both through our sales team, from the KOLs from the podium and through the referral networks, but also through our digital efforts. And we're going to continue to invest and deploy those so that at the time of decision, the oncologist knows that LOQTORZI and chemo is the regimen of choice for those patients. But again, it's a rare disease. It's going to ramp up, which is why we think peak is going to occur around year 3 of this, but we feel very confident we're going to achieve that.
Dennis Lanfear: So for all the reasons that Paul just elucidated, we see the growth of this market as a steady ramp up to peak market share and penetration probably out around year 3, so this is in a market and such as a replacement enzyme market or something where you can get out to these patients and just find them immediately convert them. These patients are in various stages of therapy. They may have been exposed to another PD-1. We're going to catch the patients that had ring chemotherapy. Those are eligible. They all benefit. Some patients, we will have to wait for them to progress to second line, but the key issue is, as Rosh Dias pointed out, we are the only first-line therapy from the FDA. We've gotten a position on all of the formularies. We're doing very, very well with the NCCM, but I would say with the building blocks are in place for the market, we see a steady ramp forward in the future.
Douglas Tsao: Okay. Great. And maybe a follow-up question on the UDENYCA franchise, I'm just curious, we're starting to see uptake of both of your on-boxes device as well as the auto-injector. I'm just curious if you have any insight in terms of how physicians are using the 2 -- those 2 dosage forms or product types. Are there sort of themes in terms of the types of patients that are getting the on-body versus the auto-injector and vice versa? Thank you.
Denny Lanfear: Paul, I guess, the question is, what sort of patient settings would they go for the auto-injector with patients settings for the on body and so on?
Paul Reider: Yes, Doug. So let me frame this in a couple of different ways. First, let's take the clinics. So the clinic segments are going to gear more towards all 3 of the presentations because they have patients who like to come back to the office the next day. They like the high-touch connectivity with their nurse and with their doctor. And so therefore, the prefilled syringe or the auto-injector are positioned for those patients. But some patients in the clinic, they want their injection experience at home. Therefore, we give them the option of the on-body device with a well-designed 5-minute injection. But if the patient wants to self-inject, and not aware of the device, they can choose the auto-injector and under 10 seconds inject themselves at the time and place that they like. So that's really how we're positioning by the patients and by the provider. The hospitals, they tend to go a little bit more with the on-body device or the prefilled syringe. So we've had good uptake with auto-injector in the hospital, but not nearly as much in the clinic because they prefer either the prefilled syringe or the on-body is the at-home reference. So that's kind of how we're seeing it. And again, being the only franchise with all three options really sets us apart from a competitive differentiation. And I think you see that in our market share growth.
Douglas Tsao: Great. Thanks.
Operator: Question comes from the line of Colleen Kusy with Baird. Your line is open.
Colleen Kusy: Thanks. Good afternoon and thanks for taking our questions. So for realizing you're not providing guidance at this point, but how to think about what the growth drivers for UDENYCA will be in 2024? Is it growing the on-body? Is it just focusing on the prefilled syringe and auto-injectors kind of thoughts around growth for UDENYCA this year? And then sorry if I missed this in the prepared remarks, but if you could just speak towards the potential of reaching cash flow positivity and if that goal is still set for 2024. Thank you.
Denny Lanfear: Thank you, Colleen. I'll let Paul handle the growth drivers for UDENYCA first, and then I'll handle your secondary question with respect to 2024. Paul?
Paul Reider: Yes, thanks for your question. Yes, I think we fully expect the on-body to be the predominant driver of our growth in 2024. As Denny mentioned that the approval of that product now opens up segments of the market that have been difficult to penetrate with our prefilled syringe and auto injectors. So we're really looking for that SKU, that presentation to drive market share growth for the remainder of the year. It will be buoyed and facilitated by our payer coverage, which I mentioned was doubled this year versus last year and that payer coverage extends to all three product presentations. So, really not inhibited by payer coverage by each of those presentations. So, where we've got it. We've got all three, and we will leverage that as we continue to execute.
Denny Lanfear: Thanks, Paul. With respect to your secondary question, I would first say with 2024 is shaping up to be a more predictable year than 2023. And so far as we had to focus a lot on getting approvals. We focused on getting the on-body approval. We did it successfully. We went and got LOQTORZI approved and the FDA that was -- that took a little time. We got that done. And then we rolled into the launches, particularly the launch of the on-body the launch of the auto-injector and now launch like LOQTORZI. So the trajectory over 2024 is continued revenue growth. We'll see more like LOQTORZI as we go on the year -- quarter. And we believe that we'll also see continued growth with respect to UDENYCA for the reasons that Paul just laid out. The issue is like how steep will that growth curve be, how much growth. And what we are constrained by is the real world looking experience, looking backward trying -- we are very early in these launches. We have just gotten out there. With respect to LOQTORZI, we're making very good progress on the formularies, but it's a rare disease. Now we have to acquire the patients and so on. But I think we're off to a very good start. So we don't want to forecast with respect to our forward looking, although clearly, as I indicated, growth will continue. So it's a question of when and how that will go up, that remains very clearly in our sights is to move forward in that direction. But the growth is something that we're happy with.
Colleen Kusy: Great. Thanks for taking our questions.
Denny Lanfear: Thank you, Colleen.
Operator: There are no further questions at this time. Mr. Denny Lanfear, I turn the call back over to you.
Denny Lanfear: Thank you, operator. Thank you all for joining us on call today, and thank you for the opportunity to enumerate for you the progress we've made across all of our key overtures, particularly with respect to driving our sales and advancing our tumor microenvironment focused pipeline, and we look forward to pricing you of our progress at our next call. Thank you.
Operator: Today's conference call. You may now disconnect.
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